Inflammatory Bowel DiseaseM-TECCUNCT06031038
Impact of Telemonitoring in the Management of Complex IBD in Spain: M-TECCU
A study testing TECCU Software in people with Inflammatory Bowel Disease and Crohn's Disease, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 30 sites in Spain.
Trial summary
M-TECCU is a study: multicenter, randomized and open. It consists of two parallel groups to compare the efficacy of the TECCU web-based telemonitoring system to achieve and maintain activity remission in patients with moderate-high complexity inflammatory bowel disease compared to usual clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- What is being tested?
- TECCU Software
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 30 sitesSpain
- Study dates
- 15 Sep 2020to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18a
- IBD (CD or UC) diagnosed according to ECCO criteria
- Start treatment with immunosuppressants and/or biological therapies due to luminal activity
- signed informed consent
Who cannot join
- Pregnant women
- Presence of active perianal disease, ileoanal reservoir, or definitive stoma
- Patients with mental illness or other poorly controlled illness
- Patients with active cancer diagnosis
- Terminal patients and/or palliative care (SECPAL)
- Family members of the research team
Show all 9Show fewer
- Patients without a telephone line to connect with a mobile, tablet and/or computer / Inability to drive
- Cognitive or linguistic difficulties
- Patients included in another experimental study
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Spain30 sites
Hospital Universitario de Alicante
Alicante
Hospital Germans Trias i Pujol
Badalona
Hospital Universitario de Burgos
Burgos
Hospital Universitario de Cabueñes
Cabueñes
Hospital Universitario Reina Sofía
Córdoba
Hospital de Cruces
Cruces
Hospital General Universitario de Elche
Elche
Hospital Universitario de Fuenlabrada
Fuenlabrada
Hospital Trueta de Girona
Girona
Hospital Universitario San Cecilio
Granada
Hospital de Huelva
Huelva
Hospital Gregorio Marañón
Madrid
Hospital La Paz
Madrid
Hospital La Princesa
Madrid
Hospital Puerta del Hierro
Madrid
Hospital Ramon y Cajal
Madrid
Hospital de Manresa
Manresa
Hospital Morales Meseguer
Murcia
Hospital Parc Taulí de Sabadell
Sabadell
Hospital Infanta Sofía
San Sebastián de los Reyes
Hospital Nuestra Señora de la Candelaria
Santa Cruz de Tenerife
Hospital Marqués de Valdecilla
Santander
Hospital Universitario de Santiago
Santiago de Compostela
Consorci Sanitari de Terrassa
Terrassa
Hospital Universitario Mutua Terrassa
Terrassa
Hospital Universitario y Politécnico la Fe
Valencia, Valencia, 46026
Hospital Clínico Universitario Valencia
Valencia
Hospital de Vigo
Vigo
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Hospital Universitario Miquel Servet
Zaragoza
About this study
Official title: Impact of Telemonitoring in the Management of Complex Inflammatory Bowel Disease in Spain: TECCU Multicenter Study
M-TECCU is a study: multicenter, randomized and open. It consists of two parallel groups to compare the efficacy of the TECCU web-based telemonitoring system to achieve and maintain activity remission in patients with moderate-high complexity inflammatory bowel disease compared to usual clinical practice.
Read the detailed description
Clinical trial with an open, randomized and controlled non-inferiority medical device, in which the impact of a follow-up method through a web telemonitoring platform on the time in clinical remission of patients with complex IBD is evaluated, in comparison with the usual follow-up in outpatient clinics.
Patients with complex IBD are considered to be those who receive treatment with immunosuppressants or biological therapies to control the luminal activity of their disease. Patients carry out periodic controls for the disease according to a pre-established schedule based on national and international clinical guidelines. The patients in the telemonitoring group (G_TECCU) follow these controls through the TECCU platform, a web system that allows them to fill in questionnaires related to the clinical variables under study and communicate freely with healthcare personnel during pre-established controls and when the patient deems it necessary. On the other hand, the patients of the control group (G_Control) carry out the controls according to the same schedule as G_TECCU, but following the usual clinical practice.
- Being tested
- TECCU Software
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECCU SoftwareOther
patient monitoring by software application
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients receive conventional care in the outpatient clinics of the participating specialized IBD units in Spain. This is complemented with telephone controls for those aspects that can be controlled by this means according to standard clinical practice. Likewise, an individual assessment will be made if, after the situation generated by SARS-COV2, any participating center should have to modify face-to-face consultations for telephone consultations, following the usual clinical practice at all times. |
| Web telemonitoring group (G_TECCU) | Active comparator | Monitoring and control will be done remotely through the TECCU comprehensive management platform, configured to respond to the specific needs of IBD patients. Patients will connect to the internet from a computer or an APP application on a tablet or mobile terminal, Android or iOS. They will have to complete questionnaires related to the variables under study at each control according to a pre-established follow-up plan. During the follow-up, the number of controls may be increased (intensive monitoring) according to the evolution of the patient, who in turn will be able to perform controls on demand. The healthcare personnel of each IBD unit will receive the information of each patient filtered through an intelligent alert generation system from which an integrated intervention protocol will be followed to adjust the treatment and follow-up plan in each case. Receives: Other: TECCU Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical remission
To compare the time in remission of patients with complex IBD (require immunosuppressants and/or biologics to control their luminal inflammatory activity) controlled with the TECCU intervention (G_TECCU) with respect to usual clinical practice (G_Control) after 52 weeks of follow-up.
Measured: 52 weeks
Secondary outcomes (1)
cost-effectiveness
Carry out a cost-effectiveness analysis based on the direct and indirect costs generated during the 12-month follow-up in G_TECCU and G_control.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start15 Sep 2020
- Primary completion13 Oct 2021
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To compare the time in remission of patients with complex IBD (require immunosuppressants and/or biologics to control their luminal inflammatory activity) controlled with the TECCU intervention (G\_TECCU) with respect to usual clinical practice (G\_Control) after 52 weeks of follow-up.
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariam Aguas, Principal investigator, Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031038
- Sponsor's protocol ID
- M-TECCU
- Acronym
- M-TECCU
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Del Hoyo J, Nos P, Faubel R, Munoz D, Dominguez D, Bastida G, Valdivieso B, Correcher M, Aguas M. A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial. J Med Internet Res. 2018 Nov 27;20(11):e11602. doi: 10.2196/11602.
PubMed 30482739Aguas M, Del Hoyo J, Faubel R, Munoz D, Dominguez D, Bastida G, Navarro B, Barrios A, Valdivieso B, Correcher M, Nos P. A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2018 Dec 21;7(12):e190. doi: 10.2196/resprot.9639.
PubMed 30578197Del Hoyo J, Aguas M. Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Jan;19(1):206-207. doi: 10.1016/j.cgh.2020.06.016. No abstract available.
PubMed 33339564Aguas M, Del Hoyo J, Vicente R, Barreiro-de Acosta M, Melcarne L, Hernandez-Camba A, Madero L, Arroyo MT, Sicilia B, Chaparro M, Martin-Arranz MD, Pajares R, Mesonero F, Manosa M, Martinez P, Chacon S, Tosca J, Marin S, Sanroman L, Calvo M, Monfort D, Saiz E, Zabana Y, Guerra I, Varela P, Garcia-Garcia S, Faubel R, Corsino P, Porto-Silva S, Brunet-Mas E, Gonzalez M, Gutierrez A, Nos P; GETECCU. The TECCU-Based Telemonitoring Platform for Inflammatory Bowel Disease Is Cost-Effective: A Multicenter GETECCU Trial. Clin Gastroenterol Hepatol. 2026 May 25:S1542-3565(26)00351-4. doi: 10.1016/j.cgh.2026.05.004. Online ahead of print.
PubMed 42190979Aguas M, Del Hoyo J, Vicente R, Barreiro-de Acosta M, Melcarne L, Hernandez-Camba A, Madero L, Arroyo MT, Sicilia B, Chaparro M, Martin-Arranz MD, Pajares R, Mesonero F, Manosa M, Martinez P, Chacon S, Tosca J, Marin S, Sanroman L, Calvo M, Monfort D, Saiz E, Zabana Y, Guerra I, Varela P, Baydal V, Faubel R, Corsino P, Porto-Silva S, Brunet E, Gonzalez M, Gutierrez A, Nos P. Telemonitoring of Active Inflammatory Bowel Disease Using the App TECCU: Short-Term Results of a Multicenter Trial of GETECCU. J Med Internet Res. 2024 Nov 18;26:e60966. doi: 10.2196/60966.
PubMed 39189160
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Telemonitoring in the Management of Complex Inflammatory Bowel Disease in Spain: TECCU Multicenter Study
- ClinicalTrials.gov ID
- NCT06031038
- Acronym / sponsor ID
- M-TECCU / M-TECCU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis UlcerosaUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
M-TECCU is a study: multicenter, randomized and open. It consists of two parallel groups to compare the efficacy of the TECCU web-based telemonitoring system to achieve and maintain activity remission in patients with moderate-high complexity inflammatory bowel disease compared to usual clinical practice.
Detailed description
Clinical trial with an open, randomized and controlled non-inferiority medical device, in which the impact of a follow-up method through a web telemonitoring platform on the time in clinical remission of patients with complex IBD is evaluated, in comparison with the usual follow-up in outpatient clinics.
Patients with complex IBD are considered to be those who receive treatment with immunosuppressants or biological therapies to control the luminal activity of their disease. Patients carry out periodic controls for the disease according to a pre-established schedule based on national and international clinical guidelines. The patients in the telemonitoring group (G_TECCU) follow these controls through the TECCU platform, a web system that allows them to fill in questionnaires related to the clinical variables under study and communicate freely with healthcare personnel during pre-established controls and when the patient deems it necessary. On the other hand, the patients of the control group (G_Control) carry out the controls according to the same schedule as G_TECCU, but following the usual clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To compare the time in remission of patients with complex IBD (require immunosuppressants and/or biologics to control their luminal inflammatory activity) controlled with the TECCU intervention (G_TECCU) with respect to usual clinical practice (G_Control) after 52 weeks of follow-up.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients receive conventional care in the outpatient clinics of the participating specialized IBD units in Spain. This is complemented with telephone controls for those aspects that can be controlled by this means according to standard clinical practice. Likewise, an individual assessment will be made if, after the situation generated by SARS-COV2, any participating center should have to modify face-to-face consultations for telephone consultations, following the usual clinical practice at all times. |
| Web telemonitoring group (G_TECCU) | Active comparator | Other: TECCU SoftwareMonitoring and control will be done remotely through the TECCU comprehensive management platform, configured to respond to the specific needs of IBD patients. Patients will connect to the internet from a computer or an APP application on a tablet or mobile terminal, Android or iOS. They will have to complete questionnaires related to the variables under study at each control according to a pre-established follow-up plan. During the follow-up, the number of controls may be increased (intensive monitoring) according to the evolution of the patient, who in turn will be able to perform controls on demand. The healthcare personnel of each IBD unit will receive the information of each patient filtered through an intelligent alert generation system from which an integrated intervention protocol will be followed to adjust the treatment and follow-up plan in each case. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥18a
- IBD (CD or UC) diagnosed according to ECCO criteria
- Start treatment with immunosuppressants and/or biological therapies due to luminal activity
- signed informed consent
Key exclusion criteria (9 listed)
- Pregnant women
- Presence of active perianal disease, ileoanal reservoir, or definitive stoma
- Patients with mental illness or other poorly controlled illness
- Patients with active cancer diagnosis
- Terminal patients and/or palliative care (SECPAL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TECCU Softwarepatient monitoring by software application | Other | Web telemonitoring group (G_TECCU) |
Primary outcome
clinical remission
Time frame: 52 weeks
To compare the time in remission of patients with complex IBD (require immunosuppressants and/or biologics to control their luminal inflammatory activity) controlled with the TECCU intervention (G_TECCU) with respect to usual clinical practice (G_Control) after 52 weeks of follow-up.
1 secondary outcome
cost-effectiveness
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 30482739Del Hoyo J, Nos P, Faubel R, Munoz D, Dominguez D, Bastida G, Valdivieso B, Correcher M, Aguas M. A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial. J Med Internet Res. 2018 Nov 27;20(11):e11602. doi: 10.2196/11602.
- Background: PubMed 30578197Aguas M, Del Hoyo J, Faubel R, Munoz D, Dominguez D, Bastida G, Navarro B, Barrios A, Valdivieso B, Correcher M, Nos P. A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2018 Dec 21;7(12):e190. doi: 10.2196/resprot.9639.
- Background: PubMed 33339564Del Hoyo J, Aguas M. Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Jan;19(1):206-207. doi: 10.1016/j.cgh.2020.06.016. No abstract available.
- Derived from this study: PubMed 42190979Aguas M, Del Hoyo J, Vicente R, Barreiro-de Acosta M, Melcarne L, Hernandez-Camba A, Madero L, Arroyo MT, Sicilia B, Chaparro M, Martin-Arranz MD, Pajares R, Mesonero F, Manosa M, Martinez P, Chacon S, Tosca J, Marin S, Sanroman L, Calvo M, Monfort D, Saiz E, Zabana Y, Guerra I, Varela P, Garcia-Garcia S, Faubel R, Corsino P, Porto-Silva S, Brunet-Mas E, Gonzalez M, Gutierrez A, Nos P; GETECCU. The TECCU-Based Telemonitoring Platform for Inflammatory Bowel Disease Is Cost-Effective: A Multicenter GETECCU Trial. Clin Gastroenterol Hepatol. 2026 May 25:S1542-3565(26)00351-4. doi: 10.1016/j.cgh.2026.05.004. Online ahead of print.
- Derived from this study: PubMed 39189160Aguas M, Del Hoyo J, Vicente R, Barreiro-de Acosta M, Melcarne L, Hernandez-Camba A, Madero L, Arroyo MT, Sicilia B, Chaparro M, Martin-Arranz MD, Pajares R, Mesonero F, Manosa M, Martinez P, Chacon S, Tosca J, Marin S, Sanroman L, Calvo M, Monfort D, Saiz E, Zabana Y, Guerra I, Varela P, Baydal V, Faubel R, Corsino P, Porto-Silva S, Brunet E, Gonzalez M, Gutierrez A, Nos P. Telemonitoring of Active Inflammatory Bowel Disease Using the App TECCU: Short-Term Results of a Multicenter Trial of GETECCU. J Med Internet Res. 2024 Nov 18;26:e60966. doi: 10.2196/60966.
Related trials for Inflammatory Bowel Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariam Aguas principal investigator
Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECCU Software in people with Inflammatory Bowel Disease and Crohn's Disease, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 30 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical remission (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06031038, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.